A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis

Phase 3

Completed

• Conditions: Compensated Cirrhosis; Chronic Hepatitis C; Hepatitis C Virus Infection
• Interventions: Drug: ABT-493/ABT-530

• Registration Number: NCT02642432
• Lead Sponsor: AbbVie

Brief Summary

The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-07
• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-28
• Study First Posted: 2015-12-30
• Primary Completion: 2016-10-27
• Study Completion: 2017-02-10
• Disposition First Submitted: 2017-02-10
• Disposition First Submitted QC: 2017-02-10
• Disposition First Posted: 2017-02-13
• Results First Submitted: 2017-08-17
• Results First Submitted QC: 2017-08-29
• Results First Posted: 2017-09-26
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-09
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 (GT1,2,4,5,6) infection
• Chronic HCV infection
• Subject must be HCV treatment-naïve or have failed prior HCV treatment
• Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease

Exclusion Criteria

• Positive test result at screening for Hepatitis B surface antigen or anti-human immunodeficiency virus (anti-HIV) antibody
• HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype
• Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABT-493/ABT-530	ABT-493/ABT-530	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	12 weeks after the last actual dose of study drug	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Post-treatment Relapse	From the end of treatment through 12 weeks after the last dose of study drug	Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment, excluding reinfection.
Percentage of Participants With On-treatment Virologic Failure	Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment	On-treatment virologic failure was defined as confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.